PMA P240003S002
- Device
- Minima Stent System
- Applicant
- Renata Medical, Inc.
- PMA number
- P240003
- Supplement
- S002
- Product code
- PNF
- Decision date
- 2025-01-16
- Classification
- Cardiovascular
- Generic name
- Aortic stent
- Approval order statement
- Approval for a shelf-life extension to 24 months for the Minima Stent System.
Current openFDA PMA Record#
- Device
- Minima Stent System
- Applicant
- Renata Medical, Inc.
- PMA number
- P240003
- Supplement
- S002
- Product code
- PNF
- Generic name
- Aortic stent
- Decision date
- 2025-01-16
- Decision code
- APPR
- Date received
- 2024-11-05
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a shelf-life extension to 24 months for the Minima Stent System.